MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10601
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	ST Segment Elevation (2059); Thrombosis (2100)
Date of Event	09/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent thrombosis occurred.The target lesion was located in the left anterior descending artery and diagonal branch.A 3.00 x 24mm and a 2.50x12mm synergy ii drug-eluting stents were implanted to treat the lesion and the procedure was completed.However, 24 hours after the procedure, the patient came back to the cath lab with st segment and troponins elevation and the stents were noted to have thrombosed.Repeat angiogram was performed and an attempt was made to re-wire the vessel but the wire would not cross the vessel.Post procedure prior to the st-elevation, the patient threw up their brilinta.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8024721
• Report Number: 2134265-2018-62503
• Device Sequence Number: 13726435
• Product Code: NIQ
• UDI-Device Identifier: 08714729840039
• UDI-Public: 08714729840039
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2020
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0022416502
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR